Skip to content

Zuhal Reed, Esq. | Risk Management Senior Staff Attorney | Medmarc

Medmarc Blog (blog.medmarc.com)

FDA Guidance on AI Medical Devices: Predetermined Change Control Plans

September 25, 2025

One of the challenges regulators face with AI-enabled medical devices is that they are not static products. Unlike a traditional implant or diagnostic tool, the device that receives FDA approval may...

Impact of Federal Funding Freeze on Clinical Trials and Patient Safety

February 25, 2025

In January 2025, the Trump administration implemented a temporary freeze on federal financial assistance programs, including grants and loans, to review their alignment with the administration’s...

A Guide to FDA's Labeling Guidelines on Biosimilars and the Implications for Products Liability

October 11, 2023

The field of biopharmaceuticals has witnessed significant advancements in recent years, particularly in the realm of biosimilars. Biosimilars are biological products that are similar to an...

The Modernization of Cosmetics Regulation Act of 2022

March 28, 2023

Cosmetic companies did not expect to be impacted so heavily by the 4155-page, 1.7 trillion-dollar omnibus spending bill enacted by Congress for this year. Within this bill is the Modernization...

FDA Proposes Two New Rules to Eliminate Contradictions with the HHS’ Common Rule

December 01, 2022

The US Food and Drug Administration (FDA) has long held rules governing clinical investigations and studies that support research and marketing applications. These regulations are stricter...